enterade in carcinoid/non-carcinoid syndrome neuroendocrine tumor patients with quality of life limiting bowel frequency

Conditions: Neuroendocrine Tumor; Carcinoid Syndrome

Summary: this is an open-label phase ii basket study evaluating the ability of enterade® to reduce bowel frequency in neuroendocrine tumor (net) patients with carcinoid syndrome and non-carcinoid syndrome.

primary objective: - to assess the ability of enterade to reduce bowel movement frequency in net patients with and without carcinoid syndrome. secondary objectives: * to assess subject-reported health-related quality of life measures in subjects before and after compound administration. * to characterize the side effect profile and tolerability of the compound as measured by the number of total 8-oz enterade® bottles consumed throughout the trial. * to evaluate changes in serum electrolytes before and after administration of the compound. * to assess differences in intravenous fluid requirement and/or hospitalizations for dehydration in patients between observation period and active enterade® period. * to evaluate differences in utilization of standard-of-care anti-diarrheal medications in patients between observation period and enterade® period. * to compare subjective bloating and flatulence in patients before and after administration of the compound. * to evaluate changes in patient weight before and after administration of the compound. exploratory objectives: * to assess changes in serum and stool inflammatory markers before and after the study compound. * to evaluate changes in fecal lactoferrin before and after study compound administration.

Eligibility criteria:
inclusion criteria: carcinoid syndrome: participants must have histopathologically confirmed neuroendocrine tumor with 4 or more bowel movements per day on standard anti-diarrheal regimen (which includes somatostatin analogs and/or telotristat ethyl). additionally, a plasma 5-hiaa, or a urine 24-hour 5-hiaa or plasma secretory hormone levels (vip, gastrin) above the upper limit of normal per reference lab. patients may be grouped into this cohort based on a previous plasma 5-hiaa level though the final cohort determination will be made based upon the 5-hiaa level drawn during screening. non-carcinoid syndrome: participants who have histopathologically confirmed neuroendocrine tumor and have 4 or more bowel movements per day on standard anti-diarrheal regimen (which may or may not include somatostatin analogs), but do not have elevated results for one of the following: plasma 5-hiaa, or 24-hour urine 5-hiaa or other plasma secretory hormone levels (vip, gastrin) above the upper limit of normal per reference lab. patients may be grouped into this cohort based on a previous plasma 5-hiaa level though the final cohort determination will be made based upon the 5-hiaa level drawn during screening * ecog performance status ≤ 2 (karnofsky ≥60%) * ability to tolerate thin liquids by mouth at the time of enrollment. * ability to understand and the willingness to sign a written informed consent document. * subject who are willing to take enterade® as instructed will be eligible. exclusion criteria: * known allergy to stevia. * uncontrolled intercurrent illness including, but not limited to, ongoing or active * clostridium difficile infection or history of clostridium difficile infection. * participants with a history of inflammatory bowel disease, irritable bowel syndrome, bariatric surgery and/or celiac disease. * participants with psychiatric illness/social situations that would limit compliance with study requirements. * patients who have had enterade® within the past 3 months. * pregnant or breastfeeding women. the safety of enterade® has not been validated in this patient population.